BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS100 INTRA-AORTIC BALLOON PUMP, CHINESE, 220V

    MDR report key: 23165883 · Received September 29, 2025

    Report

    Report Number
    2249723-2025-0004032
    Event Type
    Malfunction
    Date Received
    September 29, 2025
    Date of Event
    September 8, 2025
    Report Date
    September 29, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K031636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO CHARACTER LIMITATION IN E1 FOR EVENT SITE NAME & EVENT SITE ADDRESS. EVENT SITE NAME - (B)(6) HOSPITAL. EVENT SITE ADDRESS - (B)(6). A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE UNIT. AFTER ON-SITE INSPECTION, IT WAS FOUND THAT THE FAILURE WAS CAUSED BY THE CONDENSER TUBE FALLING OFF. WHEN ENTERING THE MANUAL CONTROL VALVE IN THE BACKGROUND, IT WAS FOUND THAT THERE WAS AN OBVIOUS LEAK AND THE CONNECTION OF THE PIPELINE WAS CHECKED AND IT WAS FOUND THAT THE CONDENSER TUBE FELL OFF. FSE ADJUSTED THE JOINT OF THE CONDENSER TUBE AND FIX IT AND CONDUCT A BALLOON TEST ON THE MACHINE. THE MACHINE HAS PASSED ALL THE PERFORMANCE AND SAFETY INDEX TESTS SPECIFIED BY THE FACTORY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE, THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) HAD AN ALARM AND CAUSING AN AUTOMATIC INFLATION FAILURE OCCURRED. THERE WAS NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1772161 CS100 INTRA-AORTIC BALLOON PUMP, CHINESE, 220V SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-3013-45

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown UNKNOWN.